Management of Diabetes in the Emergency Room: a Randomized Trial of an Insulin Protocol.
This study will examine two questions: 1. Whether insulin treatment of high blood sugar in patients with diabetes while they are in the emergency room will improve how quickly they recover from illness if they need to be hospitalized. 2. Whether immediately beginning long lasting insulin detemir in patients with diabetes when they are admitted to hospital from the emergency room will improve how quickly they recover from the illness which necessitated hospitalization.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Management of Hyperglycemia in the Emergency Room: A Randomized Clinical Trial of a Subcutaneous Insulin Aspart Protocol Coupled With Rapid Initiation of Basal Bolus Insulin Prior to Hospital Admission Versus Usual Care|
- Length of Stay in the Hospital [ Time Frame: from hospital admission to hospital discharge ] [ Designated as safety issue: No ]
- Hospital Length of Stay [ Time Frame: days ] [ Designated as safety issue: No ]hospital length of stay in days
- Average Blood Glucose During the Hospital Admission [ Time Frame: from admission to discharge ] [ Designated as safety issue: No ]
- Frequency of Hypoglycemia [ Time Frame: from hospital admission to discharge ] [ Designated as safety issue: Yes ]
- Efficacy of Blood Glucose Lowering During the Emergency Room Stay [ Time Frame: from emergency room admission to discharge ] [ Designated as safety issue: No ]
- Frequency of Hypoglycemia During Emergency Room Therapy With Insulin [ Time Frame: from emergency room admission to discharge ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2008|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 1-aspart detemir
these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
Drug: insulins aspart and detemir
insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER. If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.
No Intervention: 2 usual care
these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||David Baldwin, MD||Rush University Medical Center|